Pentostatin and Rituximab in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

February 1, 2013 updated by: Pharmatech Oncology

Phase II Multicenter Trial Of Pentostatin and Rituximab In Patients With Previously Treated and Untreated Low Grade B-Cell Non-Hodgkin's Lymphoma (NHL) Including Chronic Lymphocytic Leukemia (CLL)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining pentostatin and rituximab in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate in patients with low-grade B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with pentostatin and rituximab.
  • Determine the duration of response, median time to progression, and survival of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV alone on day 1 of course 1 only. Patients then receive rituximab IV and pentostatin IV on days 8, 15, and 22. An additional course with both drugs is administered on days 36, 43, and 50. Patients with progressive disease or a complete response receive no further treatment. Patients with responsive disease, but less than a complete response, receive one additional course of therapy as above.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 50 non-Hodgkin's lymphoma and 50 chronic lymphocytic leukemia patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Rancho Mirage, California, United States, 92270
        • Cancer and Blood Institute of the Desert
      • Redding, California, United States, 96001
        • Redding Medical Center
    • Maryland
      • Clinton, Maryland, United States, 20735
        • Oncology-Hematology Associates, P.A.
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology/Oncology Associates, P.C.
      • Syracuse, New York, United States, 13210
        • Hematology Oncology Associates of Central New York, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed low-grade non-Hodgkin's lymphoma

    • REAL classification:

      • B-cell chronic lymphocytic leukemia
      • Prolymphocytic leukemia
      • Small lymphocytic lymphoma
      • Follicular center lymphoma (grade I, II, or III)
      • Extranodal marginal zone B-cell lymphoma Malt type

    • International Working Group classification:

      • Small lymphocytic/chronic lymphocytic leukemia (CLL)

        • CLL with lymph node involvement allowed
      • Small lymphocytic plasmacytoid
      • Follicular small cleaved cell
      • Follicular mixed small and large cell
      • Follicular predominantly large cell

  • Measurable disease

    • Lymph node more than 1 cm in longest transverse diameter NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 months

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 5 times upper limit of normal

Renal:

  • Creatinine less than 2.0 mg/dL
  • BUN normal
  • Urinalysis normal

Cardiovascular:

  • LVEF normal in patients with history of stable heart disease for at least 2 years

Other:

  • HIV negative
  • No thyroid disease with thyroid function that cannot be maintained in the normal range
  • No other prior malignancy unless progression free for more than 5 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior rituximab, Y2B8, or iodine I 131 tositumomab allowed provided at least 6 months have elapsed and patient has had clear disease progression
  • No other concurrent immunotherapy

Chemotherapy:

  • No more than 6 prior chemotherapy drugs
  • No more than 3 prior treatments with pentostatin
  • At least 3 weeks since prior chemotherapy
  • No prior cumulative lifetime dose of more than 480 mg/m2 of doxorubicin or an equivalent dose of any anthracycline
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No concurrent radiotherapy to an indicator lesion

Surgery:

  • Not specified

Other:

  • No other concurrent investigational drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmatech Oncology

Investigators

  • Study Chair: Judy Poehlman, Pharmatech Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

November 9, 2001

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

July 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069021
  • PHARMATECH-N007
  • PHARMATECH-20001631
  • SUPERGEN-PHARMATECH-N007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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